Trauma, MultipletraumaNCT05175872
Factors Affecting Mortality and Morbidity in Trauma Patients Followed in Intensive Care Unit
An observational study of Trauma, Multiple and Trauma Injury, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial summary
In this study, the demographic and clinical characteristics of trauma patients followed up in the Intensive Care Unit of the Anesthesiology and Reanimation Clinic of the Health Sciences University Okmeydanı Training and Research Hospital for a 2-year period were evaluated prospectively to determine the morbidity and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Multiple, Trauma Injury
- How many people
- 194 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2019to 15 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All trauma patients older than 18 years of age followed up in the anesthesia and reanimation unit of the investigator's hospital with the approval of the Ethics Committee of Okmeydanı Training and Research Hospital will be included in the study.
Who may be able to join
- Trauma Patients Followed up in the Intensive Care Unit between 14 October 2019 and 15 October 2021
- All trauma patients over the age of 18 who signed the informed consent form and agreed to participate in the trial
Who cannot join
- Patients under the age of 18
- Patients who refused to participate in the study
- Non-traumatic patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Okmeydani Education and Research Hospital
Istanbul
About this study
In this study, the demographic and clinical characteristics of trauma patients followed up in the Intensive Care Unit of the Anesthesiology and Reanimation Clinic of the Health Sciences University Okmeydanı Training and Research Hospital for a 2-year period were evaluated prospectively to determine the morbidity and mortality rates and to determine the factors affecting these rates. data.
Read the detailed description
Trauma is an important health problem that causes increased morbidity and mortality. Most of the patients are taken into intensive care and followed up in intensive care with severe and multitrauma and constitute an important part of the critical diseases followed in the intensive care unit. At the same time, these fatal injuries cause a serious public health problem both economically and socially.
According to World Health Organization data, 5.8 million people die each year due to trauma. Trauma is seen more frequently at a young age and the most common cause is motor vehicle accidents and it is the first cause of death between 1-44 years. There is a strong relationship between deaths caused by trauma and factors such as age, gender, cause of trauma, and trauma area. In addition, the duration of ICU and mechanical ventilator stay, supportive treatments, trauma scores, and scores such as APACHE 2 and SOFA routinely used in intensive care have been shown to be strongly associated with mortality.
Therefore, the demographic data, trauma scores, mechanical ventilator requirement, renal failure, inotropic need, intensive care scores such as APACHE 2, SOFA, re-operation, re-operation, intensive care stay, blood replacement need, wound infection and morbidity and mortality in trauma patients will be effective.
- Conditions
- Trauma, Multiple, Trauma Injury
- Keywords
- trauma, mortality, morbidity
- Medical subject headings
- Multiple Trauma, Accidental Injuries, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Injury Severity Score
The Injury Severity Score (ISS) assesses the combined effects of the multiply-injured patients and is based on an anatomical injury severity classification.
The ISS is calculated as the sum of the squares of the highest AIS code in each of the three most severely injured ISS body regions. These body regions are:
- Head or neck
- Face
- Chest
- Abdominal or pelvic contents
- Extremities or pelvic girdle
- External Injury Severity Scores range from 1 to 75. If an injury is assigned an AIS of 6 (identifying a currently untreatable injury), the ISS score is automatically assigned 75.
Measured: during the procedure
Clinical features
Inotropic requirement, renal failure, mechanical ventilation requirement, re-operation, need for intensive care unit, blood replacement requirement, wound infection, discharge from intensive care unit, 28-day mortality, hospital mortality, mortality, number of stay days in intensive care unit during intensive care follow-up , 20/5000 history of drug use and hospital stay days will be recorded.
Measured: during the procedure
Secondary outcomes (1)
Surgical Apgar Score
Surgical Apgar Score (SAS) is used for predicting the occurrence of major postoperative morbidities and mortality after general and vascular surgery. SAS is a 10-point score based on 3 easily obtained parameters: the estimated blood loss, lowest heart rate, and lowest mean arterial pressure during surgery
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start14 Oct 2019
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Kilinc Berktas, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Namigar Turgut, Prof.Dr., Study director, Okmeydani Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175872
- Sponsor's protocol ID
- 928
- Acronym
- trauma
- Status last verified
- Dec 2021
- First submitted
- 3 Jan 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Mortality and Morbidity in Trauma Patients Followed in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05175872
- Acronym / sponsor ID
- trauma / 928
- Conditions
- Trauma, Multiple, Trauma Injury
- Keywords
- trauma, mortality, morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the demographic and clinical characteristics of trauma patients followed up in the Intensive Care Unit of the Anesthesiology and Reanimation Clinic of the Health Sciences University Okmeydanı Training and Research Hospital for a 2-year period were evaluated prospectively to determine the morbidity and mortality rates and to determine the factors affecting these rates. data.
Detailed description
Trauma is an important health problem that causes increased morbidity and mortality. Most of the patients are taken into intensive care and followed up in intensive care with severe and multitrauma and constitute an important part of the critical diseases followed in the intensive care unit. At the same time, these fatal injuries cause a serious public health problem both economically and socially.
According to World Health Organization data, 5.8 million people die each year due to trauma. Trauma is seen more frequently at a young age and the most common cause is motor vehicle accidents and it is the first cause of death between 1-44 years. There is a strong relationship between deaths caused by trauma and factors such as age, gender, cause of trauma, and trauma area. In addition, the duration of ICU and mechanical ventilator stay, supportive treatments, trauma scores, and scores such as APACHE 2 and SOFA routinely used in intensive care have been shown to be strongly associated with mortality.
Therefore, the demographic data, trauma scores, mechanical ventilator requirement, renal failure, inotropic need, intensive care scores such as APACHE 2, SOFA, re-operation, re-operation, intensive care stay, blood replacement need, wound infection and morbidity and mortality in trauma patients will be effective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All trauma patients older than 18 years of age followed up in the anesthesia and reanimation unit of the investigator's hospital with the approval of the Ethics Committee of Okmeydanı Training and Research Hospital will be included in the study.
Key inclusion criteria (2 listed)
- Trauma Patients Followed up in the Intensive Care Unit between 14 October 2019 and 15 October 2021
- All trauma patients over the age of 18 who signed the informed consent form and agreed to participate in the trial
Key exclusion criteria (3 listed)
- Patients under the age of 18
- Patients who refused to participate in the study
- Non-traumatic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Injury Severity Score
Time frame: during the procedure
The Injury Severity Score (ISS) assesses the combined effects of the multiply-injured patients and is based on an anatomical injury severity classification. The ISS is calculated as the sum of the squares of the highest AIS code in each of the three most severely injured ISS body regions. These body regions are: * Head or neck * Face * Chest * Abdominal or pelvic contents * Extremities or pelvic girdle * External Injury Severity Scores range from 1 to 75. If an injury is assigned an AIS of 6 (identifying a currently untreatable injury), the ISS score is automatically assigned 75.
Clinical features
Time frame: during the procedure
Inotropic requirement, renal failure, mechanical ventilation requirement, re-operation, need for intensive care unit, blood replacement requirement, wound infection, discharge from intensive care unit, 28-day mortality, hospital mortality, mortality, number of stay days in intensive care unit during intensive care follow-up , 20/5000 history of drug use and hospital stay days will be recorded.
1 secondary outcome
Surgical Apgar Score
Time frame: during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Namigar Turgut, Prof.Dr. study director
Okmeydani Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, Multiple and Trauma Injury, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injury Severity Score (time frame: during the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.